1. Field of the Invention
This invention concerns the use of 7.alpha.-methyltestosterones in the treatment of pseudopregnancy, galactorrhea and mastitis in mammals. Pseudopregnancy (false pregnancy, pseudocyesis), galactorrhea and the need to terminate lactation are clinical problems often encountered by doctors and veterinarians. In the case of pseudopregnancy, the patient has milk, enlarged mammary glands and altered behavior patterns such as depression, or "grouchiness", and often self nursing. Although many cases of pseudopregnancy will undergo remission without treatment, the behavior changes are of concern and the stimulated mammary glands may be subject to mastitis. Therapeutic regimens now available often give uncertain response or take 4 to 8 days before an acceptable clinical response is observed. In addition, some existing treatment regimens often require retreatment because of recurrence of the condition after treatment is stopped.
2. Prior Art
Known methods for treating pseudopregnancy include testosterone injection, diethylstilbestrol injection or oral and megestrol acetate oral; Johnston, S. D., "Pseudopregnancy in Kirk R W" (ed), Current Veterinary Therapy, VI., p. 1240, Philadelphia, W. B. Saunders Co. (1977). The treatment of pseudopregnancy in dogs with testosterone propionate is also described by G. M. Spy, in "The Veterinary Record", Vol. 79, No. 10, p, 281 (1966). Gerber et al. describes the treatment of pseudopregnancy in dogs with 17.alpha.-methyl-19-nortestosterone (methyloestrenolone) in "The Veterinary Record", Vol. 76, No. 39, p. 1089 (1964). The relationship between prolactin levels and pseudopregnancy has been observed by several investigators. Smith et al., "Endocrinology", Vol. 98, No. 6, pp. 1370-77 (1976); Smith et al., "Serum Levels of Luteinizing Hormone and Progesterone During the Estrous Cycle, Pseudopregnancy and Pregnancy in the Dog", "Endocrinology", Vol. 94, pp. 404-412 (1974); Archer, D. F., "Current Concepts of Prolactin Philosophy in Normal and Abnormal Conditions", "Fertility and Sterility", Vol. 28, pp. 125-134 (1977); Hadley, J. F., "Uncongugated Oestrogen and Progesterone Concentrations in the Blood of Bitches with False Pregnancy and Pyometra", "The Veterninary Record", Vol. 96, pp. 545-547, (1975); Meites, J., "Neuroendocrinology of Lactation", "Journal of Investigational Dermatology", Vol. 63, pp. 119-124 (1974), discloses that the development of mammary glands in primates and rodents can be induced by combination of estrogen, progesterone, prolactin and growth hormone. Stoye, M., "Untersuchungen uber die Moglichkeit pranataler and galaktogener Infektionen mit Ancylostoma caninum Ercolani 1859 (Ancylostomidae) biem Hund", "Zbl. Vet. Med.," B 20, pp. 1-39 (1973); and Knight, et al., "Serum Prolactin During Pregnancy and Lactation in the Beagle Bitch", "The Veterinary Record", Vol. 101, pp. 202-203 (1977) disclose that canine lactation can be stimulated and/or maintained by prolactin alone.
The therapeutic regimens now available for treating pseudopregnancy and/or galactorrhea often give uncertain response or take four to eight days before an acceptable clinical response is observed. In addition, some existing treatment regimens require retreatment because of recurrence of the condition after treatment is stopped. Compared to the prior art treatments, the treatment embodied in the instant invention is more effective, the response is more rapid and recurrence of the condition soon after therapy is minimized.
The 7.alpha.-methyl testosterones which are used in the methods of this invention are described in U.S. Pat. No. 3,341,557. Methods for preparing the 7.alpha.-methyltestosterones and a description of how they can be made into pharmaceutical compositions are also disclosed in said patent. The essential material constituting a disclosure of how to prepare the 7.alpha.-methyltestosterones and how to formulate them into pharmaceutical compositions is incorporated here by reference from U.S. Pat. No. 3,341,557.